MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THE VEST APX SYSTEM; PERCUSSOR, POWERED-ELECTRIC

Model Number	PVAPX1HC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
It was reported that the patient developed eating difficulties which prevent the patient from holding down food after using the vest apx device system.The patient was admitted to the hospital due to eating difficulties and discharged, the exact date is unknown.Shortly after this event the patient was admitted again in the hospital for eating difficulties, approximately 10 days where she was diagnosed with third hiatal hernia, as well as esophageal thickening, and narrowed esophagus caused by the hernia¿s shift which required medical treatment (hospitalization, esophagogastroduodenoscopy, balloon dilation, dietary restrictions).The patient is awaiting an additional procedure to correct the condition.Patient has not used the vest airway clearance device for over 90 days after the events.There was no allegation of a device malfunction.The device is being returned due to the patient¿s discontinuance of device therapy.No further information was available at the time of this report.

• Brand Name: THE VEST APX SYSTEM
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25385703
• Report Number: 3008145987-2026-00040
• Device Sequence Number: 18310285
• Product Code: BYI
• UDI-Device Identifier: 00887761967243
• UDI-Public: (01)00887761967243
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: PVAPX1HC
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female